BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V4-I FB

    MDR report key: 1549953 · Received November 13, 2009

    Report

    Report Number
    9681684-2009-00105
    Event Type
    Malfunction
    Date Received
    November 13, 2009
    Date of Event
    November 7, 2007
    Report Date
    November 8, 2007
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON IMMEDIATE INSPECTION OF THE AREA, THE STAFF MEMBER AND UNIT MANAGER NOTICED THE RAIL STOPPER HAD BECOME DISLODGED. IT WAS NOT DETERMINED IF THE RAIL STOPPER BECAME DISLODGED PRIOR TO, OR AS A RESULT OF THE LIFT MAKING CONTACT WITH THE RAIL STOPPER. STAFF MEMBER AND UNIT MANAGER ALSO LOOKED FOR, AND COULD NOT FIND THE TRACK END CAP ANYWHERE IN THE ROOM. THE INITIAL INSTALLATION CHECK LIST REVEALED THAT THE INSTALLATION WAS AS PER SPEC WHEN RELEASED TO CUSTOMER. TWO DIMPLES WERE NOTED AT THE TRACK END, WHICH WERE CAUSED BY THE RAIL STOPPER SET-SCREW (ONE DIMPLE CAUSED DURING ORIGINAL INSTALL OF RAIL STOPPER AND ONE DIMPLE CAUSED DURING THE RE-INSTALL OF RAIL STOPPER UPON COMPLETION OF LOAD TEST). THE TRACK DID NOT SHOW SIGNS OF ANY DAMAGE DUE TO THE RAIL STOPPER BEING PUSHED OFF THE END OF THE TRACK BY THE LIFT. THE ORIGINAL BHM RAIL STOPPER DID NOT LOOK DAMAGED OR WORN AND PERFORMED AS DESIGNED WHEN TESTED ON-SITE. ALL INSTALLATION PROCEDURES AND PRACTICES WERE ADHERED TO BY THE INSTALLER, INCLUDING THE INSTALLATION OF ALL REQUIRED RAIL STOPPERS AT THE TIME OF INSTALL, PROPER RE-INSTALLATION OF RAIL STOPPER UPON COMPLETION OF LOAD TEST, AND PROPER DOCUMENTATION UPON COMPLETION OF INSTALL. THE FACILITY STAFF STATE THEY DID NOT ATTEMPT TO UNINSTALL OR ALTER THE ORIGINAL TRACK INSTALL, INCLUDING THE RELOCATION OF THE RAIL STOPPER OR LIFT. IT IS THEREFORE IMPOSSIBLE TO FIND THE ROOT CAUSE OF THE INCIDENT. THE MFR RECOMMENDS THE CUSTOMER HAVE THIS PRODUCT INSPECTED AND REPAIRED (IF NEEDED) BY A QUALIFIED TECHNICIAN AND THAT THESE ACTIONS ARE RECORDED. IT IS ALSO RECOMMENDED THAT THE CUSTOMER HAVE ALL SIMILAR PRODUCTS INSPECTED AND REPAIRED (IF NEEDED) BY A QUALIFIED TECHNICIAN.

    Description of Event or Problem · 1

    THE FACILITY REPORTS DURING PREPARATION FOR A TRANSFER, A STAFF MEMBER NOTICED THE LIFT WAS "HALF OFF" THE END OF THE TRACK. HE ATTEMPTED TO MOVE THE LIFT BACK ONTO TRACK USING THE HANDSET. IN DOING SO, THE LIFT FELL FROM TRACK ONTO THE BED. LIFT DID NOT FALL ON PT OR STAFF MEMBER. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V4-I FB LIFT, PATIENT, AC-POWERED FNG BHM MEDICAL, INC. 9110001

    Patients

    Seq Age Sex Outcome Treatment
    1